Recalls / Class II
Class IID-0983-2020
Product
Testosterone Cypionate Injection,TESTOSTERONE CYP IN GRAPESEED OIL [10ML] 200 MG/ML INJECTABLE, For IM Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0530-1
- Affected lot / code info
- Lot #: 03252019+51850, Exp 7/6/2020; 04252019+52098, Exp 6/29/2020; 04292019+52108, Exp 6/29/2020; 05012019+52132, Exp 10/22/2020; 05202019+52268, Exp 11/10/2020; 05222019+52290, Exp 11/10/2020; 05302019+52334, Exp 11/20/2020; 07082019+52594, Exp 12/29/2020; 07102019+52619, Exp 12/29/2020; 07292019+52762, Exp 8/12/2020; 07312019+52778, Exp 8/12/2020; 09102019+52898, Exp 1/16/2021; 09112019+52905, Exp 1/18/2021
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 1990 Westwood Blvd Ste 135, N/A, Los Angeles, California 90025-4650
Distribution
- Quantity
- N/A
- Distribution pattern
- U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Timeline
- Recall initiated
- 2020-01-15
- FDA classified
- 2020-03-05
- Posted by FDA
- 2020-03-11
- Terminated
- 2023-12-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0983-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.